Clinical and Laboratory Online Patient- and Research Database for Primary Immunodeficiencies in Switzerland

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
University Hospital, Basel, Switzerland
University of Bern
University Hospital, Geneva
University of Lausanne
Cantonal Hospital of St. Gallen
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT01150240
First received: June 23, 2010
Last updated: September 16, 2010
Last verified: June 2010
  Purpose

A Swiss national, multi-centre, online patient and research database will be created, using the existing ESID database server system. This database contains disease-specific data from patients with primary (inborn) immunodeficiency diseases (PID).


Condition
Primary Immunodeficiency Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Clinical and Laboratory Online Patient- and Research Database for Primary Immunodeficiencies in Switzerland

Further study details as provided by University of Zurich:

Estimated Enrollment: 800
Study Start Date: October 2006
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Primary Immunodeficiency Disease
Patients with primary Immunodeficiency disease (PID)

Detailed Description:

The project aims to compile clinical and laboratory data of patients with primary immunodeficiencies (PID) in order to improve diagnosis, classification, prognosis and therapy. The online technology offers features not available in former databases such as access control,security functionality, and maintenance of data integrity during transactions and system errors, online back up, online optimization, scalability and online SQL-queries as well as a long term documentation of patients.

Furthermore the database can be used for the submission and storage of molecular diagnostic results and thus allow the compilation of genotype and phenotype observations, which is of essential and immediate use for the patient himself and patient care. An attending physician may gain information on similar cases of a rare PID disease in Switzerland and European countries and use these insights for therapy. In addition, it will be possible to obtain an insight on side effects. Thus, the system also meets the requirements of an optimal platform for Phase IV studies of post-licensing drug surveillance-programs.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with Primary Immunodeficiency Disease (PID), followed in a PID centre, primary care hospitals or private practice

Criteria

Inclusion Criteria:

  • Primary Immunodeficiency Disease (PID)

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01150240

Locations
Switzerland
University Hospital Basel
Basel, Switzerland
University Hospital Bern
Bern, Switzerland
University Children's Hospital Geneva
Geneva, Switzerland
University Hospital Lausanne
Lausanne, Switzerland
Children's Hospital of Eastern Switzerland and Cantonal Hospital
St. Gallen, Switzerland
University Children's Hospital Zurich
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
University Hospital, Basel, Switzerland
University of Bern
University Hospital, Geneva
University of Lausanne
Cantonal Hospital of St. Gallen
Investigators
Principal Investigator: Arthur Helbling, Prof. University Bern, Inselspital
Principal Investigator: Christoph Hess, Prof. University Basel, University Hospital
Principal Investigator: Ayse H Ozsahin, Prof. University Geneva, University Hospital
Principal Investigator: Francois Spertini, Prof. University Lausanne, University Hospital
Principal Investigator: Hugo Ubieto, MD Children's Hospital of Eastern Switzerland, St. Gallen
Principal Investigator: Reinhard A Seger, Prof. University Zürich, University Children's Hospital
  More Information

No publications provided

Responsible Party: Prof. Dr. med. R.A. Seger, University Children's Hospital Zurich
ClinicalTrials.gov Identifier: NCT01150240     History of Changes
Other Study ID Numbers: PID_CH_Registry06
Study First Received: June 23, 2010
Last Updated: September 16, 2010
Health Authority: Switzerland: Ethikkommission

Keywords provided by University of Zurich:
Primary Immunodeficiency Disease

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on August 18, 2014